Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00001137
First received: January 28, 2000
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Successive suppressed viral load measures [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Genotypic or phenotypic resistance [ Time Frame: Measured at baseline and study completion ] [ Designated as safety issue: No ]
  • Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater [ Time Frame: Measured throughout ] [ Designated as safety issue: Yes ]
  • Absolute number and percentage of CD4 and CD8 T cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
  • Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
  • Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
  • Levels of immune activation markers, including CD8, CD38, and HLA-DR cells [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV-1 latency or replication in tissue or cellular reservoirs [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ] [ Designated as safety issue: No ]
  • Syncytium and non-syncytium inducing (SI/NSI) phenotype [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ] [ Designated as safety issue: No ]
  • Metabolic and neurologic complications [ Time Frame: Measured at baseline, Week 16, Week 48, and study completion ] [ Designated as safety issue: Yes ]
  • Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV [ Time Frame: Measured 144 weeks after randomization ] [ Designated as safety issue: No ]
  • Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs) [ Time Frame: Measured at baseline, Week 16, and study completion ] [ Designated as safety issue: No ]
  • Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities [ Time Frame: Measured at baseline, Week 48, and study completion ] [ Designated as safety issue: Yes ]
  • Quality of life scores [ Time Frame: Measured at baseline, Week 48, and study completion ] [ Designated as safety issue: No ]
  • Subject-reported patterns of adherence [ Time Frame: Measured at baseline, Week 48, and study completion ] [ Designated as safety issue: No ]
  • Estimated inpatient, outpatient, and total costs [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]

Enrollment: 5982
Study Start Date: January 2000
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in this study will be HIV-infected men and women who are enrolled in an ACTG parent study and are receiving HAART.

Criteria

Inclusion Criteria

  • HIV-1 infected
  • Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol.
  • Willing to provide consent for the release and use of clinical data from the parent study
  • Life expectancy of at least 24 weeks
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria

  • Active alcohol or drug abuse that may interfere with the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001137

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Kaiser Permanente LAMC
Los Angeles, California, United States, 90027
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Willow Clinic
Menlo Park, California, United States, 94025
UC Davis Med Ctr
Sacramento, California, United States, 95814
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Univ of California, San Francisco/San Francisco General Hosp
San Francisco, California, United States, 94110
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Marin County Specialty Clinic
San Rafael, California, United States, 94903
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Denver Public Health CRS
Denver, Colorado, United States, 80204
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, United States, 303652225
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Tripler Army Med Ctr
Tripler AMC, Hawaii, United States, 96859
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Iowa
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, United States, 52242
United States, Louisiana
Tulane Med Ctr Hosp
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State Univ. CRS
Detroit, Michigan, United States, 48201
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Hennepin County Medical Clinic
Minneapolis, Minnesota, United States, 55415
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
United States, Nebraska
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
United States, New Jersey
Cooper Univ. Hosp. CRS
Camden, New Jersey, United States, 08103
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hosp. Ctr. CRS
Bronx, New York, United States, 10457
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Mount Sinai Med Ctr
New York, New York, United States, 10029
Cornell Univ Med Ctr
New York, New York, United States, 10021
Beth Israel Med Ctr
New York, New York, United States, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Chelsea Ctr
New York, New York, United States, 10021
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Community Health Network Inc
Rochester, New York, United States, 14642
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
AIDS Care CRS
Rochester,, New York, United States, 14607
United States, North Carolina
Wake County Department of Health
Chapel Hill, North Carolina, United States, 27514
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28203
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Cleveland Clinic
Cleveland, Ohio, United States, 44106-5083
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Oregon
The Research & Education Group-Portland CRS
Portland, Oregon, United States, 97210
United States, Pennsylvania
Presbyterian Medical Center - Univ. of PA
Norristown, Pennsylvania, United States, 19401
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
United States, Texas
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75390
Peabody Health Center CRS
Dallas, Texas, United States, 75215
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, United States, 23219
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Puerto Rico-AIDS CRS
San Juan,, Puerto Rico, 00935
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Constance A. Benson, MD Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
Study Chair: Ann C. Collier, MD University of Washington
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00001137     History of Changes
Other Study ID Numbers: ACTG A5001, 1U01AI068636, AACTG A5001
Study First Received: January 28, 2000
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
Treatment Experienced
Treatment Naive
Virus Replication
AIDS-Related Opportunistic Infections
HIV-1
Risk Factors
Incidence
RNA, Viral
Anti-HIV Agents
Viral Load
Lipodystrophy
Nervous System
Cardiovascular System
Neurologic Symptoms

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014